{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Fort Lauderdale",
      "state": "FL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98317",
      "recalling_firm": "Trividia Health, Inc.",
      "address_1": "2400 Nw 55th Ct",
      "address_2": "N/A",
      "postal_code": "33309-2672",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.",
      "recall_number": "Z-1548-2026",
      "product_description": "Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices.  Description/Item:  Walgreens TRUE METRIX GO Kit/RF4001-01BK,  CVS TRUE METRIX GO Kit/RF4007-01,  Meijer TRUE METRIX GO Kit/RF4019-01,  Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01,  HEB TRUE METRIX GO Kit/RF4031-01,  Hyvee TRUE METRIX GO Kit/RF4048-01,  Rite Aid TRUE METRIX GO Kit/RF4066-01,  TopCo TRUE METRIX GO Kit/RF4209-01,  TRUE METRIX GO  Kit/RF4H01-01BK,  TRUE METRIX GO  NFRS Meter Only/RF4H01-40,  TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK,  TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK,  TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK,  TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK",
      "product_quantity": "1,407,465",
      "reason_for_recall": "The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.",
      "recall_initiation_date": "20260206",
      "center_classification_date": "20260312",
      "report_date": "20260318",
      "code_info": "Device Item/UDI-DI:  RF4001-01BK/311917178691, RF4007-01/50428560402, RF4019-01/708820721098, RF4023-01/21292009335, RF4031-01/41220136131, RF4048-01/75450843576, RF4066-01/11822002783, RF4209-01/36800234567, RF4H01-01BK/21292006112, RF4H01-40/21292009793.  International: RF4i29-11BK/N/A, RF4i81-11BK/N/A, RF4i82-11BK/21292012229, RF4i82-12BK/21292009984.  Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX GO Owner's Booklet/ RF4TVH03 Rev 57 and prior,  TRUE METRIX GO Owner's Booklet (English)/RF4TVH35 Rev 51 and prior, TRUE METRIX GO Owner's Booklet (Spanish)/RF4TVH35S Rev 51 and prior, TRUE METRIX GO Blood Glucose Monitoring System IFU Trividia House Brand/ RF4ITV16 Rev 55 and prior,  TRUE METRIX GO System Instructions for Use (IFU) for Trividia Health UK Limited/ RF4UKT16 Rev 56 and prior,  Trividia Health LATAM- TRUE METRIX GO System IFU/ RF4LAT16 Rev 51 and prior,  TRUE METRIX GO System Instructions for Use (IFU) for Trividia Health Australia/ RF4AUT16 Rev 57 and prior.  Device serial numbers: Prefix \"F\" followed by an eight-digit numeric sequence."
    }
  ]
}